DELSYM

Adverse Events

Drug Profile

Learn More

Reference

About Results

Comments

Delsym Adverse Events Reported to the FDA Over Time

How are Delsym adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Delsym, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Delsym is flagged as the suspect drug causing the adverse event.

Most Common Delsym Adverse Events Reported to the FDA

What are the most common Delsym adverse events reported to the FDA?

Completed Suicide	1595 (6.44%)
Drug Toxicity	746 (3.01%)
Cardiac Arrest	538 (2.17%)
Respiratory Arrest	484 (1.95%)
Cardio-respiratory Arrest	479 (1.93%)
Death	455 (1.84%)
Overdose	445 (1.8%)
Drug Abuse	364 (1.47%)
Intentional Drug Misuse	339 (1.37%)
Intentional Overdose	308 (1.24%)
Vomiting	232 (.94%)
	Show More
Convulsion	207 (.84%)
Somnolence	192 (.78%)
Suicide Attempt	188 (.76%)
Multiple Drug Overdose	184 (.74%)
Poisoning	179 (.72%)
Agitation	172 (.69%)
Dyspnoea	166 (.67%)
Drug Interaction	165 (.67%)
Dizziness	163 (.66%)
Blood Pressure Increased	162 (.65%)
Heart Rate Increased	160 (.65%)
Hypotension	158 (.64%)
Loss Of Consciousness	157 (.63%)
Tachycardia	157 (.63%)
Multiple Drug Overdose Intentional	154 (.62%)
Accidental Overdose	144 (.58%)
Drug Dependence	144 (.58%)
Confusional State	143 (.58%)
Hallucination	138 (.56%)
Insomnia	133 (.54%)
Incorrect Dose Administered	130 (.52%)
Nausea	127 (.51%)
Coma	118 (.48%)
Mydriasis	117 (.47%)
Medication Error	114 (.46%)
Drug Ineffective	109 (.44%)
Unresponsive To Stimuli	109 (.44%)
Pulmonary Oedema	108 (.44%)
Dysarthria	107 (.43%)
Hypertension	106 (.43%)
Tremor	104 (.42%)
Hyperhidrosis	96 (.39%)
Abnormal Behaviour	95 (.38%)
Serotonin Syndrome	92 (.37%)
Feeling Abnormal	91 (.37%)
Aggression	90 (.36%)
Anxiety	88 (.36%)
Disorientation	84 (.34%)
Psychotic Disorder	83 (.34%)
Pneumonia	82 (.33%)
Pyrexia	82 (.33%)
Delirium	81 (.33%)
Lethargy	81 (.33%)
Headache	80 (.32%)
Palpitations	79 (.32%)
Rhabdomyolysis	78 (.31%)
Condition Aggravated	76 (.31%)
Hypersensitivity	75 (.3%)
Pruritus	74 (.3%)
Depression	73 (.29%)
Diarrhoea	72 (.29%)
Fall	71 (.29%)
Toxic Anterior Segment Syndrome	69 (.28%)
Aspartate Aminotransferase Increase...	68 (.27%)
Suicidal Ideation	68 (.27%)
Alanine Aminotransferase Increased	67 (.27%)
Drug Abuser	66 (.27%)
Drug Screen Positive	66 (.27%)
Fatigue	65 (.26%)
Gait Disturbance	65 (.26%)
Urticaria	65 (.26%)
Blood Creatine Phosphokinase Increa...	64 (.26%)
Incorrect Drug Administration Durat...	63 (.25%)
Rash	63 (.25%)
Hallucination, Visual	62 (.25%)
Disturbance In Attention	61 (.25%)
Euphoric Mood	60 (.24%)
Off Label Use	59 (.24%)
Depressed Level Of Consciousness	58 (.23%)
Metabolic Acidosis	58 (.23%)
Blood Glucose Increased	56 (.23%)
Cardiac Disorder	56 (.23%)
Hepatic Failure	56 (.23%)
Pulmonary Congestion	56 (.23%)
Accidental Drug Intake By Child	55 (.22%)
Erythema	55 (.22%)
Asthenia	54 (.22%)
Sinus Tachycardia	54 (.22%)
Wrong Drug Administered	54 (.22%)
Blood Pressure Decreased	53 (.21%)
Vision Blurred	53 (.21%)
Grand Mal Convulsion	52 (.21%)
Mental Status Changes	52 (.21%)
International Normalised Ratio Incr...	51 (.21%)
Ventricular Extrasystoles	51 (.21%)
Flat Affect	50 (.2%)
Pain In Extremity	50 (.2%)
Bradycardia	49 (.2%)
Dehydration	49 (.2%)
Drug Exposure During Pregnancy	49 (.2%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Delsym, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Delsym is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Delsym

What are the most common Delsym adverse events reported to the FDA?

Medication Errors	1910 (7.71%)
Suicidal And Self-injurious Behavio...	1910 (7.71%)
Cardiac Arrhythmias	1604 (6.47%)
Neurological	1527 (6.16%)
Chemical Injury And Poisoning	1072 (4.33%)
Respiratory	1070 (4.32%)
Psychiatric	1041 (4.2%)
Cardiac And Vascular Investigations	688 (2.78%)
Fatal Outcomes	545 (2.2%)
Gastrointestinal Signs	533 (2.15%)
Epidermal And Dermal Conditions	483 (1.95%)
	Show More
Therapeutic And Nontherapeutic Effe...	426 (1.72%)
Disturbances In Thinking	414 (1.67%)
Infections - Pathogen Unspecified	352 (1.42%)
Anxiety Disorders	324 (1.31%)
Injuries	312 (1.26%)
Seizures	311 (1.26%)
Deliria	309 (1.25%)
Lower Respiratory Tract Disorders	286 (1.15%)
Hepatic And Hepatobiliary	268 (1.08%)
Hematology Investigations	261 (1.05%)
Movement Disorders	247 (1%)
Metabolic, Nutritional And Blood Ga...	232 (.94%)
Muscle	226 (.91%)
Cardiac Disorder Signs	221 (.89%)
Hepatobiliary	218 (.88%)
Decreased And Nonspecific Blood Pre...	206 (.83%)
Ocular Neuromuscular	204 (.82%)
Toxicology And Therapeutic Drug Mon...	189 (.76%)
Sleep Disorders	181 (.73%)
Allergic Conditions	180 (.73%)
Mental Impairment	172 (.69%)
Neuromuscular	169 (.68%)
Lifestyle Issues	159 (.64%)
Mood Disorders	157 (.63%)
Upper Respiratory Tract Disorders	146 (.59%)
Procedural And Device Related Injur...	141 (.57%)
Physical Examination Topics	134 (.54%)
Electrolyte And Fluid Balance Condi...	131 (.53%)
Water, Electrolyte And Mineral	126 (.51%)
Renal Disorders	125 (.5%)
Vision	124 (.5%)
Personality Disorders	123 (.5%)
Vascular Hypertensive	121 (.49%)
Psychiatric And Behavioural Symptom...	118 (.48%)
Skin Appendage Conditions	118 (.48%)
Depressed Mood Disorders	114 (.46%)
Body Temperature Conditions	110 (.44%)
Gastrointestinal Motility And Defec...	103 (.42%)
Enzyme	102 (.41%)
Musculoskeletal And Connective Tiss...	97 (.39%)
Eye	96 (.39%)
Vascular	95 (.38%)
Schizophrenia And Other Psychotic	94 (.38%)
Acid-base	93 (.38%)
Coronary Artery	90 (.36%)
Headaches	87 (.35%)
Renal And Urinary Tract Investigati...	86 (.35%)
Therapeutic Procedures And Supporti...	83 (.34%)
Central Nervous System Vascular	77 (.31%)
Angiedema And Urticaria	75 (.3%)
Appetite And General Nutritional	74 (.3%)
Heart Failures	72 (.29%)
Urinary Tract Signs	71 (.29%)
Oral Soft Tissue Conditions	68 (.27%)
Bronchial Disorders	67 (.27%)
Increased Intracranial Pressure And...	65 (.26%)
Ocular Infections, Irritations And ...	65 (.26%)
Legal Issues	63 (.25%)
Glucose Metabolism Disorders	60 (.24%)
Changes In Physical Activity	59 (.24%)
Encephalopathies	57 (.23%)
Tongue Conditions	56 (.23%)
Gastrointestinal Hemorrhages	51 (.21%)
Neonatal And Perinatal Conditions	45 (.18%)
White Blood Cell	45 (.18%)
Product Quality Issues	43 (.17%)
Bacterial Infectious	40 (.16%)
Myocardial	39 (.16%)
Skin Vascular Abnormalities	39 (.16%)
Arteriosclerosis, Stenosis, Vascula...	38 (.15%)
Joint	38 (.15%)
Neurological, Special Senses And Ps...	37 (.15%)
Bone And Joint Injuries	35 (.14%)
Administration Site Reactions	34 (.14%)
Cranial Nerve Disorders	34 (.14%)
Gastrointestinal Inflammatory Condi...	34 (.14%)
Tissue	34 (.14%)
Viral Infectious	34 (.14%)
Bone Disorders	33 (.13%)
Vascular Hemorrhagic	32 (.13%)
Salivary Gland Conditions	31 (.13%)
Injuries By Physical Agents	30 (.12%)
Gastrointestinal Conditions	28 (.11%)
Platelet	27 (.11%)
Obstetric And Gynecological Therape...	26 (.1%)
Coagulopathies And Bleeding Diathes...	23 (.09%)
Inner Ear And Viiith Cranial Nerve	23 (.09%)
Pleural	23 (.09%)
Hematological And Lymphoid Tissue T...	22 (.09%)
Spleen, Lymphatic And Reticulendoth...	22 (.09%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Delsym, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Delsym is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Delsym According to Those Reporting Adverse Events

Why are people taking Delsym, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication	1384
Product Used For Unknown Indication	1193
Premedication	919
Suicide Attempt	484
Cough	397
Nasopharyngitis	284
	Show More
Insomnia	191
Prophylaxis	189
Hypersensitivity	145
Pruritus	118
Nasal Congestion	111
Ill-defined Disorder	86
Preoperative Care	82
Sleep Disorder	78
Upper Respiratory Tract Infection	63
Intentional Overdose	61
Hypotension	61
Drug Abuse	55
Mydriasis	54
Influenza	50
Completed Suicide	49
Rash	49
Cataract Operation	42
Accidental Exposure	37
Sinus Congestion	32
Sleep Disorder Therapy	32
Headache	31
Sinusitis	30
Pain	29
Pyrexia	27
Influenza Like Illness	26
Urticaria	25
Nausea	25
Seasonal Allergy	24
Hyperemesis Gravidarum	23
Sinus Disorder	22
Multiple Allergies	22
Ophthalmological Examination	21
Off Label Use	20
Intentional Drug Misuse	20
Allergy Prophylaxis	19
Rhinorrhoea	17
Antitussive Therapy	17
Chemotherapy	17
Drug Abuser	16
Drug Exposure During Pregnancy	16
Bronchitis	15
Reversible Ischaemic Neurological D...	14
Anaesthesia	13
Dermatitis Contact	13
Blood Pressure Management	13

Drug Labels

Label	Labeler	Effective
Delsym	Reckitt Benckiser, Inc.	21-DEC-09
Delsym Night Time Cough And Cold	Reckitt Benckiser, Inc.	13-SEP-10
Delsym Night Time Multi Symptom	Reckitt Benckiser, Inc.	15-SEP-10
Delsym Childrens Night Time Cough And Cold	Reckitt Benckiser, Inc.	15-SEP-10
Delsym	Rebel Distributors Corp	12-JAN-11
Delsym Childrens Night Time Cough And Cold	Reckitt Benckiser LLC	14-DEC-11
Delsym Night Time Multi-symptom	Reckitt Benckiser LLC	28-DEC-11
Delsym Night Time Cough And Cold	Reckitt Benckiser LLC	28-DEC-11
Delsym Cough Relief Plus Soothing Action	Reckitt Benckiser LLC	12-JAN-12
Delsym Cough Relief Plus Soothing Action	Reckitt Benckiser LLC	14-MAR-12
Delsym	Reckitt Benckiser LLC	11-JUL-12
Delsym	Reckitt Benckiser LLC	11-JUL-12
Delsym	Physicians Total Care, Inc.	30-AUG-12
Delsym	Reckitt Benckiser LLC	09-OCT-12
Delsym	Reckitt Benckiser LLC	10-OCT-12
Delsym Cough Plus Chest Congestion Dm	Reckitt Benckiser LLC	26-MAR-13
Delsym Cough Plus Cold Day Time	Reckitt Benckiser LLC	26-MAR-13
Childrens Delsym Cough Plus Chest Congestion Dm	Reckitt Benckiser LLC	26-MAR-13
Delsym Cough Plus Cold Night Time	Reckitt Benckiser LLC	04-APR-13
Childrens Delsym Cough Plus Cold Night Time	Reckitt Benckiser LLC	05-APR-13
Delsym Cough Plus Soothing Action	Reckitt Benckiser LLC	30-APR-13
Delsym Cough Plus Soothing Action	Reckitt Benckiser LLC	01-MAY-13

Delsym Case Reports

What Delsym safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Delsym. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

Comments

Share your experience with Delsym.